Obesity is a difficult to treat chronic condition defined by a body mass index (BMI=mass/height2 [kg/m2]) greater than 30. For obese persons, excessive weight is commonly associated with increased risk of cardiovascular disease, diabetes, degenerative arthritis, endocrine and pulmonary abnormalities, gallbladder disease and hypertension. Additionally, such persons are highly likely to experience psychological difficulties because of lifestyle restrictions such as reduced mobility and physical capacity, due to back pain, joint problems, and shortness of breath. In severe cases, this can contribute to absenteeism and unemployment. Moreover, impairment of body image can lead to significant psychological disturbances. Repeated failures of dieting and exercise to resolve the problem of obesity can result in feelings of despair and the development of clinical depression.
Bariatric surgery is often recommended for persons suffering from morbid obesity. Preferably, the invasive treatment is accompanied by changes in lifestyle, such as improved regulation of eating habits and an appropriate exercise regimen. Such lifestyle changes are dependent upon the self-discipline and cooperation of the patient.
A book entitled, Textbook of Gastroenterology, 3rd edition, edited by Yamada (Lippincott, Williams & Wilkins), which is incorporated herein by reference, has in Chapter 10 thereof a description of the physiology of gastric motility and gastric emptying.
An abstract entitled, “Gastric myoelectrical pacing as therapy for morbid obesity: Preliminary results,” by Cigaina et al., retrieved on Dec. 24, 2000 from the Web-site http://www.med-online.com/transneuronix/Product/abstract.htm, which is incorporated herein by reference, describes a method for applying monopolar and bipolar gastric stimulation to achieve weight loss.
An abstract entitled, “Implantable gastric stimulator (IGS) as therapy for morbid obesity: Equipment, surgical technique and stimulation parameters,” by Cigaina et al., retrieved on Dec. 24, 2000 from the Web-site http://www.med-online.com transneuronix/Product/abstract.htm, which is incorporated herein by reference, describes techniques of electrical signal therapy designed to treat obesity.
Stein et al., in an article entitled, “Carrots and sticks: Impact of an incentive/disincentive employee flexible credit benefit plan on health status and medical costs,” American Journal of Health Promotion, May/June 1999, V5, I13, 5, which is incorporated herein by reference, describes providing incentives relating to medical care.
Giuffrida, in an article entitled, “Should we pay the patient? Review of financial incentives to enhance patient compliance,” Biomedical Journal, vol. 315, pp. 703-707, 1997, which is incorporated herein by reference, describes providing incentives for enhanced patient compliance.
PCT Publication WO 06/018851 to Kliger et al., which is assigned to the assignee of the present application and is incorporated herein by reference, describes gastric apparatus including one or more sensors adapted to generate respective sensor signals responsive to activity of a gastrointestinal tract of a subject. A control unit is adapted to receive and analyze the sensor signals and to determine that an eating event has occurred, responsive to at least one of the sensor signals and a threshold. The control unit identifies an aspect of at least one of the sensor signals deriving from rhythmic activity of the gastrointestinal tract that is not indicative of current eating by the subject, and modifies the threshold responsive to the aspect of the signals that derives from activity that is not indicative of current eating.
U.S. Pat. No. 5,188,104 to Wernicke et al., which is incorporated herein by reference, describes a method for treating patients with compulsive eating disorders, including the steps of detecting a preselected event indicative of an imminent need for treatment of the specific eating disorder of interest, and responding to the detected occurrence of the preselected event by applying a predetermined stimulating signal to the patient's vagus nerve appropriate to alleviate the effect of the eating disorder of interest. For example, the preselected event may be a specified level of food ingestion by the patient within a set interval of time, or the commencement of a customary mealtime according to the patient's circadian cycle, or the passage of each of a sequence of preset intervals of time, or the patient's own recognition of the need for treatment by voluntarily initiating the application of the stimulating signal to the vagus nerve. In cases in which the disorder is compulsive eating to excess, the stimulating signal is predetermined to produce a sensation of satiety in the patient. The occurrence of the preselected event is detected by summing the number of swallows of food by the patient within the set interval of time. In cases where the disorder is compulsive refusal to eat (anorexia nervosa), the stimulating signal is predetermined to produce a sensation of hunger or to suppress satiety in the patient. In operation of a stimulus generator for controlling and treating compulsive overeating (including binge eating), a pulsed signal from a pulse generator is applied to excitation/sensing electrodes, and the amplitude of the signal on these electrodes is a function of the impedance between them, which varies according to whether the esophagus is empty or has food passing through it (and therefore, between the electrodes). The peak signal amplitude on the electrodes is detected and averaged by a peak detector over a predetermined interval of time. This may be calibrated to differentiate between different types of swallowing, such as of solids versus liquids and/or short swallows versus long swallows. The period of time in question may be selected according to the individual patient's eating habits.
U.S. Pat. No. 6,571,127 to Ben-Haim et al., which is assigned to the assignee of the present patent application and are incorporated herein by reference, describes apparatus and methods for applying signals to smooth muscle so as to modify the behavior thereof. In particular, apparatus for controlling the stomach is described in which a controller applies an electrical field to electrodes on the stomach wall so as to modify the reaction of muscle tissue therein to an activation signal, while not generating a propagating action potential in the tissue. In the context of the present patent application and in the claims, the use of such a non-excitatory signal to modify the response of one or more cells to electrical activation thereof, without inducing action potentials in the cells, is referred to as Excitable-Tissue Control (ETC). Use of an ETC signal is described in the PCT Patent Publication with respect to treating obesity, by applying the ETC signal to the stomach so as to delay or prevent emptying of the stomach. In addition, a method is described for increasing the motility of the gastrointestinal tract, by applying an ETC signal to a portion of the tract in order to increase the contraction force generated in the portion.
PCT Patent Publication WO 02/082968 to Policker et al., which is assigned to the assignee of the present patent application and is incorporated herein by reference, describes apparatus and methods for detecting the occurrence of an eating event by a subject and analyzing the quantity and characteristics of the food ingested.
Gastric banding is the weight loss technique of choice for many surgeons. Among the commercially available gastric bands are LAPBAND (Bioenterics, Carpinteria, Calif.) and SAGB (Swedish Adjustable Gastric Band; Obtech Medical, 6310 Zug, Switzerland). In gastric banding, an inflatable silicone band is placed around the upper part of the stomach, thus forming a pouch that reduces the capacity of the stomach. Upon ingestion, food passes from the esophagus to the pouch, filling it relatively quickly. This is intended to achieve a sensation of fullness faster and to maintain it for a longer period. The diameter of the passage remaining below the pouch is adjustable (by tightening or loosening the band typically using saline injected or pumped out from the band cavity), so that the band inflation will match individual parameters that are known to vary between patients and also vary in the same patient during the course of treatment. Solid intake is more sensitive to constriction than liquid intake; a restriction that reduces solid consumption significantly may have little effect on liquid consumption, whereas the tight restriction required to limit liquid consumption, might cause solid consumption to become difficult for the patient. Moreover, significant over-restriction may result in higher rates of band complications. Surgeons therefore try to find the “sweet spot” of restriction that gives the best trade-off between the need to have side-effect free solid intake but still good restriction of liquids.
PCT Publication WO 04/112563 to Ben Haim et al., which is assigned to the assignee of the present application and is incorporated herein by reference, describes inter alia an apparatus for detecting eating by a subject, comprising two electrodes, adapted for coupling to respective sites on a stomach of the subject; and a control unit, adapted to: drive a current between the electrodes, measure, responsive to the current, an electrical impedance between the sites, generate an impedance signal responsive to the measured electrical impedance, detect a change in posture of the subject by performing a posture analysis of the impedance signal, detect an indication of potential eating by the subject by performing an eating analysis of the impedance signal, and responsive to the posture analysis, interpret the impedance signal as indicative of the eating. In some embodiments, the control unit is adapted to adjust a volume of the stomach responsively to the indication of eating, optionally by tightening a controllable mechanical and/or electrical gastric device (e.g., a gastric band) around the stomach.
U.S. Pat. No. 5,868,141 to Ellias, which is incorporated herein by reference, describes an endoscopic stomach insert for reducing a patient's desire to eat.
U.S. Pat. No. 6,067,991 to Forsell, U.S. Pat. No. 5,601,604 to Vincent, U.S. Pat. No. 5,234,454 to Bangs, U.S. Pat. No. 4,133,315 to Berman et al., U.S. Pat. No. 4,416,267 to Garren et al., and U.S. Pat. Nos. 4,592,339, 5,449,368, 5,226,429 and 5,074,868 to Kuzmak, which are incorporated herein by reference, describe mechanical instruments for implantation in or around the stomach of an obese patient.
US Patent Application Publication 2003/0208212 to Cigaina, which is incorporated herein by reference, describes a removable gastric band for use in controlling obesity by allowing control and/or modification of the diameter of a patient's stomach. An electrostimulator may be incorporated into the design of the gastric band such that it would be in contact with the stomach when the gastric band is properly positioned, or implanted separately from the device.
US Patent Application Publication 2008/0097188 to Pool et al., which is incorporated herein by reference, describes techniques for quantifying the amount or rate of magnetically susceptible fluid within a gastric lumen. In one aspect, a magnetic sensor located external to the patient is configured to detect a quantity of fluid disposed within the gastric lumen. The quantity of fluid may include fluid that is contained upstream with respect to a restriction formed in the gastric lumen (e.g., by a gastric restriction device). The quantity of fluid disposed within the gastric lumen is determined by the magnetic sensor. This quantity may be evaluated over time to then calculate a real time flow rate which can then be displayed to the physician. The methods and devices allow a physician or other trained person to dynamically view real time development of fluid flow within a restricted gastric lumen and may be used in conjunction with adjustments to the gastric restriction device to achieve target or desired flow rates. In an embodiment, the gastric restriction device generally includes an adjustable band that at least partially or fully wraps around a portion of the patient's stomach or esophagus and is connected to an implantable interface that is located subcutaneously (or elsewhere) inside the patient.
PCT Publication WO 06/118790 to Maschino et al., which is incorporated herein by reference, describes techniques for treating an eating disorder with a gastric band and vagus nerve stimulation sufficient to induce afferent and/or efferent action potentials on the vagus nerve. The system comprises an implantable gastric band contacting the patient's gastrointestinal tract, and a pulse generator coupled to electrodes on the inner surface of the band for providing an electrical signal sufficient to induce afferent action potentials on the patient's vagus nerve. The gastric band preferably includes both sensing and stimulation electrodes, with the sensing electrodes being used for detecting induced afferent action potentials on the nerve and to identify which stimulation electrodes are nearest to the vagus nerve.
US Patent Application Publication 2006/0173238 to Warren, which is incorporated herein by reference, describes a dynamically controlled gastric occlusion device that monitors at least one physiological parameter that varies as a function of food intake and controls the degree of gastric constriction of an occluding device, such as a gastric band, based on the monitored physiological parameter.
US Patent Application Publication 2004/0167583 to Knudson et al., which is incorporated herein by reference, describes a method for treating at least one of a plurality of disorders of a patient characterized at least in part by vagal activity innervating at least one of a plurality of organs of the patient, including positioning a neurostimulator carrier around a body organ of the patient where the organ is innervated by at least a vagal trunk. An electrode is disposed on the carrier and positioned at the vagal trunk. An electrical signal is applied to the electrode to modulate vagal activity by an amount selected to treat the disorder. The signal may be a blocking or a stimulation signal. In an embodiment, electrodes are placed on constricting bands (such as the Lap-Band® system manufactured by Inamed Inc. (Santa Barbara, Calif., USA)), and used in obesity treatment. More preferably, the bands are not constricting thereby minimizing erosion risks otherwise associated with highly constricting bands. However, the neural blocking technology can be incorporated into such constricting bands or used in conjunction other obesity surgeries or therapies.
US Patent Application Publication 2005/0222638 to Foley et al., which is incorporated herein by reference, describes a method for treatment of obesity and other syndromes related to motor disorders of the stomach. The disclosed method utilizes a sensor to detect food entering the patient's stomach, thereby the sensor communicates with and activates at least one electrical stimulation device attached to either the stomach or the small intestine. One such sensor could be an elastic band around a portion of the stomach (e.g., passing around the stomach in the area of the lesser and greater curvatures).
U.S. Pat. No. 4,592,339 to Kuzmak et al., which is incorporated herein by reference, describes a gastric band for forming a stoma opening in a stomach for treating morbid obesity. The band is invasively placed around the stomach, and an expandable portion of the band is used to adjust the diameter of the stoma opening.
U.S. Pat. Nos. 5,449,368, 5,226,429, and 5,074,868 to Kuzmak, which are incorporated herein by reference, describe adjustable gastric bands. The size of the stoma opening of the bands can be adjusted by injecting into or removing fluid from an expandable section of the gastric bands.
U.S. Pat. No. 5,601,604 to Vincent, which is incorporated herein by reference, describes a gastric band for placement around the stomach for treating morbid obesity. The inner surface of the band is inflatable through a remote fill port. The band is invasively placed in an encircling position around the stomach by the facile closure of a single fastening means. After the band is fastened around the stomach, a fluid is injected into the inflatable inner surface, thereby constricting the stoma of the stomach.
U.S. Pat. No. 5,658,298 to Vincent et al., which is incorporated herein by reference, describes a tool for tightening a band or ligature having a buckle end and a free end during laparoscopic surgery.
PCT Publication WO 01/83019 to Vincent, which is incorporated herein by reference, describes apparatus and methods for transferring particles and fluids to or from a body of a patient, including inflating a balloon inside the body during surgical procedures to facilitate the identification of anatomical landmarks and to provide guidance for surgical dissections.
U.S. Pat. No. 5,938,669 to Klaiber et al., which is incorporated herein by reference, describes an adjustable gastric band for contracting a patient's stomach in order to fight obesity. A gastric band of a known type, implanted around the stomach and including a cavity filled with liquid, is connected by a tube to a control box and a balancing reservoir which are implanted under the skin of the patient. The box contains an electric pump and an electronic control unit capable of communicating by radio with a monitor carried by the patient and with a controller intended for the doctor. The controller can operate the pump by remote control to transfer determined volumes of liquid in a closed circuit from the gastric band to the reservoir or vice versa, to adjust the diameter of a passage in the stomach. The monitor receives and signals alarms from the control box.
U.S. Pat. No. 6,067,991 to Forsell, which is incorporated herein by reference, describes an adjustable gastric band including an elongated non-inflatable restriction member, a forming device for forming the restriction member into at least a substantially closed loop around the stomach or the esophagus to define a restriction opening, and a post-operation non-invasive adjustment device for mechanically adjusting the restriction member in the loop to change the size of the restriction opening.
U.S. Pat. No. 6,210,347 to Forsell, which is incorporated herein by reference, describes a food intake restriction device for forming a stoma opening in the stomach or esophagus of a patient. The device comprises an elongated restriction member to be formed into at least a substantially closed loop defining a restriction opening, and a controllable adjustment device for adjusting the restriction member in the loop to change the size of the restriction opening. The device further comprises a wireless remote control for controlling the adjustment device from outside the body of the patient in a non-invasive manner to assist in treating the patient for morbid obesity.
U.S. Pat. No. 6,460,543 to Forsell, which is incorporated herein by reference, describes a food intake restriction device for forming a stoma opening in the stomach or esophagus of a patient. The device comprises an elongated restriction member forming an expandable and contractible cavity formed into an at least substantially closed loop defining a restriction opening, the size of which is reduced upon expansion of the cavity and increased upon contraction of the cavity. A reservoir containing a predetermined amount of hydraulic fluid and connected to the cavity of the restriction member, and a hydraulic operation device for distributing fluid from the reservoir to the cavity to expand the cavity and for distributing fluid from the cavity to the reservoir to contract the cavity, are also implanted in a patient with morbid obesity and operated from outside the body of the patient in a non-invasive manner. A non-inflatable restriction member may alternatively be used, and hydraulically adjusted.
U.S. Pat. No. 6,453,907 to Forsell, which is incorporated herein by reference, describes an adjustable gastric band that includes an energy transmission device for wireless transmission of energy of a first form from outside the body of the patient. The band is adjusted in response to a second energy form different than the first form to vary the restricted stoma. An energy transfer device is implanted in the patient for transferring energy of the first form transmitted by the energy transmission device into energy of the second form.
U.S. Pat. No. 6,454,699 to Forsell, which is incorporated herein by reference, describes food intake restriction apparatus that includes a restriction device implanted in a patient, which engages the stomach or esophagus to form an upper pouch and a restricted stoma opening in the stomach or esophagus. The apparatus includes a source of energy external to the body of the patient, and a control device for releasing wireless energy from the source of energy from outside the body. The released wireless energy is used in connection with the operation of the restriction device, to enlarge it to allow food passage, or to contract it to substantially prevent food passage. The restriction device optionally includes at least one implanted sensor for sensing at least one physical parameter of the patient, in which case the control device may control the restriction device in response to signals from the sensor.
US Patent Application Publication 2003/0066536 to Forsell, which is incorporated herein by reference, describes food intake restriction apparatus, including an operable restriction device implanted in a patient and engaging the stomach or esophagus to form a restricted stoma opening in the stomach or esophagus. The apparatus includes a source of energy for energizing the restriction device, and a control device for releasing energy from the source of energy from outside the body of the patient. The released energy is used in connection with the operation of the restriction device to vary the size of the stoma opening to allow or substantially prevent the passage of food therethrough. The restriction apparatus optionally includes a pressure sensor for directly or indirectly sensing the pressure in the stomach. The control device may control the restriction device in response to signals from the pressure sensor.
US Patent Application Publication 2001/0011543 to Forsell, which is incorporated herein by reference, describes apparatus for treating morbid obesity or heartburn and reflux disease, including an elongated restriction member formed in a substantially closed loop around a stomach or esophagus of a human to form a stoma opening in the stomach or esophagus. The size of the stoma opening is adjustable by an implanted adjustment device. A control device is utilized to control the adjustment device, in order to either reduce or enlarge the size of the stoma opening, for example in response to the time of the day. A sensor, such as a pressure or position sensor, is surgically implanted in the body of the human so that the sensor may either directly or indirectly sense a physical parameter of the human, such as the pressure in the stomach or the human's orientation with respect to the horizontal. If in response to sensing by the sensor it is determined by the control device that a significant change in the physical parameter has occurred, then the control device controls the adjustment device to either reduce or enlarge the size of the stoma opening.
PCT Publication WO 01/41671 to Cigaina, which is incorporated herein by reference, describes a removable gastric band for controlling obesity by allowing control and/or modification of the diameter of a stomach of a patient. The gastric band comprises a closure mechanism, which allows the elongated body to close around a portion of the stomach. The gastric band can be used in conjunction with a gastric electrostimulator, and is therefore described as being potentially useful for inducing forced slimming in the initial phase of treatment for morbigenous obesity. Such electrostimulation devices may either be incorporated into the removable gastric band or located at a distance from the removable gastric band.
European Patent Application Publication 1 036 545 A2 to Moshe, which is incorporated herein by reference, describes a gastric band for attaching around a circumference of a stomach of a patient, so as to define the diameter of the stomach opening. The band comprises outer and inner surfaces, wherein the inner surface engages the stomach, and at least the outer surface is formed by an elongated member substantially non-extendable along a longitudinal axis thereof. A through-going opening is made in the elongated member and is located so as to define an end portion of the band having a predetermined length. An opposite end portion of the band is shaped so as to be insertable into the through-going opening, for adjusting a desired inner diameter of the band in its closed operating position and fastening the opposite end portion to the outer surface of the band.
U.S. Pat. No. 6,511,490 to Robert, which is incorporated herein by reference, describes a gastric banding device for implantation within a person for the treatment of morbid obesity. The gastric banding device includes an inflatable band portion dimensioned to encircle the stomach, and an inflation conduit operable for conducting a percutaneously injected inflation fluid into the band portion. The band portion is a toroidal member having a head end with first fastening means thereon and a tail end having second fastening means thereon and an inflatable shell therebetween. The outer surface of the toroidal shell in reinforced with a non-extensible, biocompatible material which serves to limit outward expansion of the shell when an inflation fluid is injected thereinto. The inner, stomach-contacting surface of the shell has a layer of an open-cell elastomeric foam affixed thereto and integral therewith. In operation, when the band is placed in an encircling relationship with the stomach, the first and second fastening means on the ends of the shell are engaged in locking relationship. An inflation fluid is injected into the shell by means of a subcutaneously implanted injection port that is in fluid communication with the inflation conduit. As the shell expands inwardly, it constricts and compartmentalizes the stomach.
U.S. Pat. No. 6,547,801 to Dargent et al., which is incorporated herein by reference, describes an implantable gastric constriction device comprising a constriction member forming a ring in its operational configuration. The constriction member includes a flexible band, of which the two ends are adjacent to one another in the operational configuration, and a means for actuating the constriction member, characterized in that, in cooperation, on the one hand, at least one end of the flexible band includes a tractile element for moving such end relative to the other end, generating a radial deformation of the constriction member, and, on the other hand, the actuating means comprises a member for pulling the tractile element.
The following patents and patent application publications, all of which are incorporated herein by reference, may be of interest:
U.S. Pat. No. 6,270,455 to Brown
U.S. Pat. No. 6,129,685 to Howard
U.S. Pat. No. 4,823,808 to Clegg et al.
U.S. Pat. No. 5,690,691 to Chen et al.
U.S. Pat. No. 5,423,872 to Cigaina
U.S. Pat. No. 5,263,480 to Wernicke et al.
U.S. Pat. Nos. 6,104,955, 6,091,992, 5,995,872, and 5,836,994 to Bourgeois
U.S. Pat. No. 6,026,326 to Bardy
U.S. Pat. No. 3,411,507 to Wingrove
U.S. Pat. No. 5,979,449 to Steer
U.S. Pat. No. 4,975,682 to Kerr et al.
U.S. Pat. No. 5,861,014 to Familoni
U.S. Pat. No. 5,716,385 to Mittal et al.
U.S. Pat. No. 6,415,178 to Ben-Haim et al.
US Patent Application Publication 2004/0098068 to Carbunaru et al.
U.S. Pat. No. 6,516,227 to Meadows et al.
US Patent Application Publication 2003/0114899 to Woods et al.
U.S. Pat. No. 6,185,452 to Schulman et al.
US Patent Application Publication 2004/0106963 to Tsukamoto et al.